Weight Management & Wellness for People With Psychiatric Disabilities

Obesity Clinical Trial

Official title:

Weight Management & Wellness for People With Psychiatric Disabilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05128045
• Other study ID #: 2016-0118
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: March 7, 2019

Study information

• Verified date: November 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to conduct a randomized controlled trial to test the effectiveness of an intervention called Nutrition and Exercise for Wellness and Recovery (NEW-R) in promoting healthy eating and increased physical activity for better weight management among psychiatric outpatients.

Description:

Weight management is a serious issue for individuals with mental health conditions, especially those who are taking psychiatric medications. The latest estimates are that over half of individuals receiving community mental health services are overweight or obese. This project's objective is to conduct a randomized controlled trial to test the effectiveness of an intervention called Nutrition and Exercise for Wellness and Recovery (NEW-R) in promoting healthy eating and increased physical activity for better weight management among psychiatric outpatients living and working in the community. It is an 8-week, recovery-oriented intervention that is co-led by a trained health educator and a certified mental health peer specialist. The study will take place at the UIC Department of Psychiatry in Chicago. Research participants will be recruited from the Department's outpatient clinics and other community programs, and randomly assigned to receive NEW-R along with services as usual or services as usual alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: March 7, 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis with a mental health disorder

• Patient of outpatient program

• Age 18 or older

• Being overweight or obese defined as BMI>=25

• Ability to understand spoken English

Exclusion Criteria:

• Residing in a nursing home

• Cardiac event in past 6 months

• Past episode of anorexia or bulimia

• Pregnancy

• Diagnosis with a terminal illness expected to result in death within 1 year

• Active alcohol or substance abuse or dependence

• Inability to provide informed consent due to diagnosis of dementia or cognitive impairment

• Inability to understand spoken English

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness
• Obesity

Intervention

Behavioral:
• NEW-R
Eight session class on nutrition, physical activity, diet, and weight management

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Perceived Competence Scale from Baseline to 8-months	Measures ability to stick with a weight management regimen and master new knowledge about diet and exercise. This 4-item scale using a 7-point Likert response format ranging from "not at all true" to "very true". The minimum value is 4 and the maximum is 28, with higher scores indicating a better outcome.	Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Primary	Change in Health Promoting Lifestyle Profile from Baseline to 8-months	Measure of health promoting behavior. This is a 26-item scale with a 4-point Likert response format ranging from "never" to "routinely". Minimum value for this scale is 26 and the maximum is 104, with higher scores indicating a better outcome. The dimensions include nutrition, spirituality, and physical activity.	Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Secondary	Change in Self-Rated Abilities for Health Practices Scale from Baseline to 8-months	Self perceived health management ability. This 7-item scale uses a 5-point Likert response format ranging from "not at all" to "completely". The minimum value is 7 and the maximum is 35, with higher scores indicating a better outcome.	Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Secondary	Change in Weight from Baseline to 8-months	Weight in pounds	Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3